Neck Pain MusculoskeletalNCT06906107
Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief
A study testing Cervical Manipulation, Exercise and Mobilization in people with Neck Pain Musculoskeletal and Neck Pain Treatment, run by Baylor University at 4 sites in United States.
Trial summary
Neck pain is a common issue that can lead to long-term disability and lost work time for many individuals. Despite numerous studies, finding effective treatment strategies has been challenging. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain Musculoskeletal, Neck Pain Treatment, Cervicalgia
- What is being tested?
- Cervical Manipulation, Exercise and Mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 70
- Primary complaint of neck pain with or without unilateral upper extremity symptoms
- Neck Disability Index (NDI) score of 10 or greater
- Numeric Pain Rating Scale score of 2 or greater
Who cannot join
- History of whiplash injury within the past 6 weeks
- Diagnosis of cervical spinal stenosis
- Bilateral upper extremity symptoms
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, rheumatoid arthritis, osteoporosis, severe atherosclerosis, dizziness, diplopia, drop attacks, bilateral numbness, nausea, prolonged history of steroid use)
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
- Two or more positive neurological signs consistent with significant nerve root compression, including any two of the following:
Show all 16Show fewer
- Muscle weakness involving a major muscle group of the upper extremity
- Diminished upper extremity muscle stretch reflex (biceps, triceps, or brachioradialis)
- Diminished or absent sensation to pinprick or light touch in any upper extremity dermatome
- Prior neck surgery
- Current pregnancy, pregnancy within 6 months, or currently lactating
- Pending legal action pertaining to their neck pain
- Currently receiving manual therapy treatment for neck pain through chiropractic or physical therapy care
- Inability to read English at the 8th grade reading level
- Inability to legally provide informed consent for any other reason
- Inability to comply with the treatment and follow-up schedule
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emplify by Bellin Health Ashwaubenon
Green Bay, Wisconsin, 54313
ActivePT
Rochester, Minnesota, 55901
PROActivePT
Syracuse, New York, 13201
ActiveTherapy Alliance
Waco, Texas, 76798
About this study
Official title: Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spinal Manipulation: A Randomized Clinical Trial
Neck pain is a common issue that can lead to long-term disability and lost work time for many individuals. Despite numerous studies, finding effective treatment strategies has been challenging. One possible reason for this is that treatments may not have been tested on the specific groups of people who would benefit most. A method was developed to identify people with neck pain who are likely to see significant improvements from a manipulation technique used by physical therapists, called cervical spine thrust joint manipulation. The investigators believe that patients identified as likely responders to cervical spine manipulation will show greater improvements in disability. The investigators aim to test whether this method works with different patients and therapists across the country through a multicenter randomized clinical trial. In this study, 160 patients with primary complaints of neck pain will be enrolled from 9 clinical sites. Designed with stringent criteria for inclusion, this study is a testament to our commitment to participant safety and the effectiveness of the treatment. Participants will be randomly assigned to one of two groups: (1) one group will receive 2 sessions of cervical spine manipulation followed by 3 sessions of exercise, and (2) the other group will receive 2 sessions of gentle hands-on treatment followed by 3 sessions of exercise. The primary goal is to measure changes in disability 4 weeks after starting treatment, with follow-ups after one week, 4 weeks, 3 months, and 6 months to assess both immediate and long-term effects. By providing crucial data on the reliability of our method in identifying patients who will benefit most from cervical spine manipulation, this study has the potential to significantly enhance decision-making leading to rapid improvement. Results from this study will provide clearer guidelines on the optimal use of cervical spine manipulation, potentially revolutionizing the way patients recover from neck pain.
Read the detailed description
This study's primary objective will examine whether a previously derived clinical prediction rule (CPR) exhibits validity for identifying a subgroup of patients who respond favorably to cervical thrust joint manipulation (C-TJM). The secondary objective will determine if patients who are positive on the derived CPR and receive C-TJM will exhibit reduced downstream healthcare costs. This multicenter randomized clinical trial will enroll 160 patients with primary complaints of neck pain. Participants will be randomized into two groups: (1) 2 sessions of C-TJM followed by 3 sessions of stretching and strengthening exercises, and (2) 2 sessions of low-grade mobilizations followed by 3 sessions of the same stretching and strengthening exercises. The primary outcome is the change in disability measured four weeks post-treatment, with pain as the secondary outcome. Follow-up assessments will occur at one week, 4 weeks, 3 months and 6 months to evaluate both short-term and long-term effects. The exact inclusion and exclusion criteria from the CPR derivation study will be used within this validation study to determine participant eligibility. Data will be collected using standardized self-report measures and physical examination, and statistical analyses will be performed using a linear mixed model with repeated measures. The investigators hypothesize that patients identified by the clinical prediction rule to benefit from C-TJM will show substantial improvements in disability and pain. This study will offer valuable insight into the effectiveness of C-TJM for neck pain. Successful validation of the clinical prediction rule could lead to more efficient and cost-effective patient care, potentially reducing the burden of neck pain on healthcare systems and improving patient outcomes. As PI, responsibilities include protocol development, training, data collection, analysis, manuscript development and dissemination of findings.
- Conditions
- Neck Pain Musculoskeletal, Neck Pain Treatment, Cervicalgia
- Being tested
- Cervical Manipulation, Exercise, Mobilization
- Keywords
- neck pain, manual therapy, physical therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ManipulationProcedure or surgery
High velocity low amplitude thrust joint manipulation to the cervical spine facet joints
ExerciseProcedure or surgery
Therapeutic exercises to the cervical, thoracic, and scapular musculature
MobilizationProcedure or surgery
Low velocity, low amplitude movements applied to the cervical spine facet joints (Grade I or II)
| Study group | Role | What they receive |
|---|---|---|
| Cervical Manipulation | Experimental | Patients will receive cervical manipulation on 2 visits, followed by 3 visits of therapeutic exercise. Receives: Procedure: Cervical Manipulation; Procedure: Exercise |
| Exercise and Mobilizations | Other | Patients will receive low-grade cervical mobilizations on 2 visits, followed by 3 visits of therapeutic exercises Receives: Procedure: Exercise; Procedure: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
10-item patient self-report measure of perceived disability. Each question is scored from 0 to 5. Minimum value of 0 and maximum value of 50. Higher scores indicate worse disability and a poorer outcome.
Measured: 6 months
Secondary outcomes (5)
Global Rating of Change Scale
A 15-point scale with options ranging from -7 (a great deal worse) to +7 (a great deal better) to determine the magnitude of change in response to intervention. Higher scores indicate a better outcome. Minimum value -7 and maximum value +7.
Measured: 6 months
Numeric Pain Rating Scale
Patients rate their pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst possible. Minimum value 0 and maximum value 10. Higher scores indicate a worse outcome.
Measured: 6 months
Fear Avoidance Beliefs Questionnaire
A 16 question outcome measure scaled from 0 to 6 with a maximum score of 96 - a higher score indicates fear avoidance behaviors. Minimum score 0 and maximum score 96.
Measured: 6 months
Medication Use
Self-report of medication use prior to, during, and after the treatment phase of the study. As this component is a self-report of medication use, scoring is not pertinent.
Measured: 6 months
Healthcare Utilization
Self-report of healthcare use prior to and after the treatment phase of the study. As this component is a self-report of healthcare use, scoring is not pertinent.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Neck Pain MusculoskeletalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Responsible party
- Principal investigator, Jessica Feda, Baylor University
- Investigators
- Jessica T Feda, DSc, Principal investigator, Baylor UniversityEmilio J Puentedura, PhD, Study director, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906107
- Sponsor's protocol ID
- 2240854-1
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD with other researchers beyond what will be published within future manuscripts and disseminations. However, if an individual researcher was to request IPD sharing upon completion of data analysis and dissemination, we would certainly consider the request.
Publications
Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, Delitto A. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004 Dec 21;141(12):920-8. doi: 10.7326/0003-4819-141-12-200412210-00008.
PubMed 15611489Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
PubMed 20634268Kaale BR, Krakenes J, Albrektsen G, Wester K. Clinical assessment techniques for detecting ligament and membrane injuries in the upper cervical spine region--a comparison with MRI results. Man Ther. 2008 Oct;13(5):397-403. doi: 10.1016/j.math.2007.03.007. Epub 2007 Nov 1.
PubMed 17936054Uitvlugt G, Indenbaum S. Clinical assessment of atlantoaxial instability using the Sharp-Purser test. Arthritis Rheum. 1988 Jul;31(7):918-22. doi: 10.1002/art.1780310715.
PubMed 3395385Hutting N, Scholten-Peeters GG, Vijverman V, Keesenberg MD, Verhagen AP. Diagnostic accuracy of upper cervical spine instability tests: a systematic review. Phys Ther. 2013 Dec;93(12):1686-95. doi: 10.2522/ptj.20130186. Epub 2013 Jul 25.
PubMed 23886844Hengeveld E, Banks K. Maitland's Vertebral Manipulation: Management of Neuromusculoskeletal Disorders - Volume 1. Elsevier Health Sciences; 2013.
Piva SR, Erhard RE, Childs JD, Browder DA. Inter-tester reliability of passive intervertebral and active movements of the cervical spine. Man Ther. 2006 Nov;11(4):321-30. doi: 10.1016/j.math.2005.09.001. Epub 2006 Jul 11.
PubMed 16837235Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55.
PubMed 16305273Tong HC, Haig AJ, Yamakawa K. The Spurling test and cervical radiculopathy. Spine (Phila Pa 1976). 2002 Jan 15;27(2):156-9. doi: 10.1097/00007632-200201150-00007.
PubMed 11805661Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine (Phila Pa 1976). 2003 Jan 1;28(1):52-62. doi: 10.1097/00007632-200301010-00014.
PubMed 12544957Cleland JA, Childs JD, Fritz JM, Whitman JM. Interrater reliability of the history and physical examination in patients with mechanical neck pain. Arch Phys Med Rehabil. 2006 Oct;87(10):1388-95. doi: 10.1016/j.apmr.2006.06.011.
PubMed 17023251Guidetti L, Placentino U, Baldari C. Reliability and Criterion Validity of the Smartphone Inclinometer Application to Quantify Cervical Spine Mobility. Clin Spine Surg. 2017 Dec;30(10):E1359-E1366. doi: 10.1097/BSD.0000000000000364.
PubMed 26905732MacDermid JC, Walton DM, Avery S, Blanchard A, Etruw E, McAlpine C, Goldsmith CH. Measurement properties of the neck disability index: a systematic review. J Orthop Sports Phys Ther. 2009 May;39(5):400-17. doi: 10.2519/jospt.2009.2930.
PubMed 19521015Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
PubMed 1834753Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
PubMed 21979312
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spinal Manipulation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06906107
- Acronym / sponsor ID
- 2240854-1
- Conditions
- Neck Pain Musculoskeletal, Neck Pain Treatment, Cervicalgia
- Keywords
- neck pain, manual therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neck pain is a common issue that can lead to long-term disability and lost work time for many individuals. Despite numerous studies, finding effective treatment strategies has been challenging. One possible reason for this is that treatments may not have been tested on the specific groups of people who would benefit most. A method was developed to identify people with neck pain who are likely to see significant improvements from a manipulation technique used by physical therapists, called cervical spine thrust joint manipulation. The investigators believe that patients identified as likely responders to cervical spine manipulation will show greater improvements in disability. The investigators aim to test whether this method works with different patients and therapists across the country through a multicenter randomized clinical trial. In this study, 160 patients with primary complaints of neck pain will be enrolled from 9 clinical sites. Designed with stringent criteria for inclusion, this study is a testament to our commitment to participant safety and the effectiveness of the treatment. Participants will be randomly assigned to one of two groups: (1) one group will receive 2 sessions of cervical spine manipulation followed by 3 sessions of exercise, and (2) the other group will receive 2 sessions of gentle hands-on treatment followed by 3 sessions of exercise. The primary goal is to measure changes in disability 4 weeks after starting treatment, with follow-ups after one week, 4 weeks, 3 months, and 6 months to assess both immediate and long-term effects. By providing crucial data on the reliability of our method in identifying patients who will benefit most from cervical spine manipulation, this study has the potential to significantly enhance decision-making leading to rapid improvement. Results from this study will provide clearer guidelines on the optimal use of cervical spine manipulation, potentially revolutionizing the way patients recover from neck pain.
Detailed description
This study's primary objective will examine whether a previously derived clinical prediction rule (CPR) exhibits validity for identifying a subgroup of patients who respond favorably to cervical thrust joint manipulation (C-TJM). The secondary objective will determine if patients who are positive on the derived CPR and receive C-TJM will exhibit reduced downstream healthcare costs. This multicenter randomized clinical trial will enroll 160 patients with primary complaints of neck pain. Participants will be randomized into two groups: (1) 2 sessions of C-TJM followed by 3 sessions of stretching and strengthening exercises, and (2) 2 sessions of low-grade mobilizations followed by 3 sessions of the same stretching and strengthening exercises. The primary outcome is the change in disability measured four weeks post-treatment, with pain as the secondary outcome. Follow-up assessments will occur at one week, 4 weeks, 3 months and 6 months to evaluate both short-term and long-term effects. The exact inclusion and exclusion criteria from the CPR derivation study will be used within this validation study to determine participant eligibility. Data will be collected using standardized self-report measures and physical examination, and statistical analyses will be performed using a linear mixed model with repeated measures. The investigators hypothesize that patients identified by the clinical prediction rule to benefit from C-TJM will show substantial improvements in disability and pain. This study will offer valuable insight into the effectiveness of C-TJM for neck pain. Successful validation of the clinical prediction rule could lead to more efficient and cost-effective patient care, potentially reducing the burden of neck pain on healthcare systems and improving patient outcomes. As PI, responsibilities include protocol development, training, data collection, analysis, manuscript development and dissemination of findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Manipulation | Experimental | Procedure: Cervical Manipulation, Procedure: ExercisePatients will receive cervical manipulation on 2 visits, followed by 3 visits of therapeutic exercise. |
| Exercise and Mobilizations | Other | Procedure: Exercise, Procedure: MobilizationPatients will receive low-grade cervical mobilizations on 2 visits, followed by 3 visits of therapeutic exercises |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 to 70
- Primary complaint of neck pain with or without unilateral upper extremity symptoms
- Neck Disability Index (NDI) score of 10 or greater
- Numeric Pain Rating Scale score of 2 or greater
Key exclusion criteria (16 listed)
- History of whiplash injury within the past 6 weeks
- Diagnosis of cervical spinal stenosis
- Bilateral upper extremity symptoms
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, rheumatoid arthritis, osteoporosis, severe atherosclerosis, dizziness, diplopia, drop attacks, bilateral numbness, nausea, prolonged history of steroid use)
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical ManipulationHigh velocity low amplitude thrust joint manipulation to the cervical spine facet joints | Procedure or surgery | Cervical Manipulation |
| ExerciseTherapeutic exercises to the cervical, thoracic, and scapular musculature | Procedure or surgery | Cervical Manipulation, Exercise and Mobilizations |
| MobilizationLow velocity, low amplitude movements applied to the cervical spine facet joints (Grade I or II) | Procedure or surgery | Exercise and Mobilizations |
Primary outcome
Neck Disability Index
Time frame: 6 months
10-item patient self-report measure of perceived disability. Each question is scored from 0 to 5. Minimum value of 0 and maximum value of 50. Higher scores indicate worse disability and a poorer outcome.
5 secondary outcomes
Global Rating of Change Scale
Time frame: 6 months
Numeric Pain Rating Scale
Time frame: 6 months
Fear Avoidance Beliefs Questionnaire
Time frame: 6 months
Medication Use
Time frame: 6 months
Healthcare Utilization
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 15611489Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, Delitto A. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004 Dec 21;141(12):920-8. doi: 10.7326/0003-4819-141-12-200412210-00008.
- Results publication: PubMed 20634268Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
- Results publication: PubMed 17936054Kaale BR, Krakenes J, Albrektsen G, Wester K. Clinical assessment techniques for detecting ligament and membrane injuries in the upper cervical spine region--a comparison with MRI results. Man Ther. 2008 Oct;13(5):397-403. doi: 10.1016/j.math.2007.03.007. Epub 2007 Nov 1.
- Results publication: PubMed 3395385Uitvlugt G, Indenbaum S. Clinical assessment of atlantoaxial instability using the Sharp-Purser test. Arthritis Rheum. 1988 Jul;31(7):918-22. doi: 10.1002/art.1780310715.
- Results publication: PubMed 23886844Hutting N, Scholten-Peeters GG, Vijverman V, Keesenberg MD, Verhagen AP. Diagnostic accuracy of upper cervical spine instability tests: a systematic review. Phys Ther. 2013 Dec;93(12):1686-95. doi: 10.2522/ptj.20130186. Epub 2013 Jul 25.
- Results publicationHengeveld E, Banks K. Maitland's Vertebral Manipulation: Management of Neuromusculoskeletal Disorders - Volume 1. Elsevier Health Sciences; 2013.
- Results publication: PubMed 16837235Piva SR, Erhard RE, Childs JD, Browder DA. Inter-tester reliability of passive intervertebral and active movements of the cervical spine. Man Ther. 2006 Nov;11(4):321-30. doi: 10.1016/j.math.2005.09.001. Epub 2006 Jul 11.
- Results publication: PubMed 16305273Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55.
- Results publication: PubMed 11805661Tong HC, Haig AJ, Yamakawa K. The Spurling test and cervical radiculopathy. Spine (Phila Pa 1976). 2002 Jan 15;27(2):156-9. doi: 10.1097/00007632-200201150-00007.
- Results publication: PubMed 12544957Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine (Phila Pa 1976). 2003 Jan 1;28(1):52-62. doi: 10.1097/00007632-200301010-00014.
- Results publication: PubMed 17023251Cleland JA, Childs JD, Fritz JM, Whitman JM. Interrater reliability of the history and physical examination in patients with mechanical neck pain. Arch Phys Med Rehabil. 2006 Oct;87(10):1388-95. doi: 10.1016/j.apmr.2006.06.011.
- Results publication: PubMed 26905732Guidetti L, Placentino U, Baldari C. Reliability and Criterion Validity of the Smartphone Inclinometer Application to Quantify Cervical Spine Mobility. Clin Spine Surg. 2017 Dec;30(10):E1359-E1366. doi: 10.1097/BSD.0000000000000364.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers beyond what will be published within future manuscripts and disseminations. However, if an individual researcher was to request IPD sharing upon completion of data analysis and dissemination, we would certainly consider the request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica T Feda, DSc principal investigator
Baylor University
Emilio J Puentedura, PhD study director
Baylor University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Manipulation, Exercise and Mobilization in people with Neck Pain Musculoskeletal and Neck Pain Treatment, run by Baylor University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06906107, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.